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U.S. Department of Health and Human Services

Medical Devices

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December 2012 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD December 2012


DEVICE: POLARIS SPINAL SYSTEM - BALLISTA II RODS
BIOMET SPINE (AKA EBI, LLC)       510(k) NO: K123451(SPECIAL)
ATTN: VIVIAN  KELLY MS, RAC       PHONE NO : 973 299 9300   
100 INTERPACE PARKWAY             SE DECISION MADE: 03-DEC-12
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS
ZIMMER, INC.                      510(k) NO: K122692(TRADITIONAL)
ATTN: ANTHONY  FRANCALANCIA       PHONE NO : 
P.O. BOX 708                      SE DECISION MADE: 03-DEC-12
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS
INTUITIVE SURGICAL, INC.          510(k) NO: K123463(SPECIAL)
ATTN: CRYSTAL  ONG                PHONE NO : 408 523 8636   
1266 KIFER ROAD BLDG. 101         SE DECISION MADE: 03-DEC-12
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM
ORTHOFIX                          510(k) NO: K122901(TRADITIONAL)
ATTN: JACKI  GEREN                PHONE NO : 214 937 2100   
3451 PLANO PARKWAY                SE DECISION MADE: 03-DEC-12
LEWISVILLE TX 75056               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BWF-5 MEDICAL LASER SERIES
LITECURE, LLC                     510(k) NO: K123031(TRADITIONAL)
ATTN: LIANG  LU                   PHONE NO : 302 709 0408   
250 Corporate Blvd. Suite B       SE DECISION MADE: 03-DEC-12
NEWARK DE 19702                   510(k) STATEMENT

DEVICE: ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT
ERAD, INC.                        510(k) NO: K120995(TRADITIONAL)
ATTN: JILLIAN M REED              PHONE NO : 860 238 7734   
23 GRISWOLD LANE                  SE DECISION MADE: 03-DEC-12
WINSTED CT 06098                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS
LENSAR, INC.                      510(k) NO: K122829(TRADITIONAL)
ATTN: SHIRLEY K MCGARVEY          PHONE NO : 702 524 3701   
2800 DISCOVERY DRIVE SUITE 100    SE DECISION MADE: 03-DEC-12
ORLANDO FL 32826                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K122660(TRADITIONAL)
ATTN: THOMAS  HIRTE               PHONE NO : 508 683 4454   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 03-DEC-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GALLEON PEDICLE SCREW SYSTEM
EVEREST SPINE, LLC                510(k) NO: K122814(TRADITIONAL)
ATTN: CHRISTINA  VACCA            PHONE NO : 440 937 4068   
33650 RESERVE WAY                 SE DECISION MADE: 03-DEC-12
AVON OH 44011                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LESSRAY
SAFERAY SPINE, LLC                510(k) NO: K123226(TRADITIONAL)
ATTN: CALLEY  HERZOG              PHONE NO : 720 883 3633   
13417 QUIVAS ST                   SE DECISION MADE: 05-DEC-12
WESTMINSTER CO 80234              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOBILE CAREGUIDE 2100 OXIMETER
REFLECTANCE MEDICAL INC           510(k) NO: K122645(TRADITIONAL)
ATTN: NANDINI  MURTHY             PHONE NO : 781 710 5378   
116 FLAUNDERS ROAD, SUITE 1000    SE DECISION MADE: 05-DEC-12
WESTBOROUGH MA 01581              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
NANOSPHERE, INC                   510(k) NO: K123197(TRADITIONAL)
ATTN: MARK  DEL VECCHIO           PHONE NO : 847 400 9000   
4088 COMMERCIAL AVENUE            SE DECISION MADE: 05-DEC-12
NORTHBROOK IL 60062               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUSON
SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K123622(TRADITIONAL)
ATTN: PATRICK  LYNCH              PHONE NO : 650 694 5658   
685 EAST MIDDLEFIELD ROAD         SE DECISION MADE: 05-DEC-12
MOUNTAIN VIEW CA 94043 0000       510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: IN:C2 SPINAL FIXATION SYSTEM
SPINE SMITH PARTNERS L.P.         510(k) NO: K122630(SPECIAL)
ATTN: CLIFTON (CHRIS)  NAIVAR     PHONE NO : 512 637 2068   
93 Red River                      SE DECISION MADE: 05-DEC-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS CA 15-3 II CALCHECK 5
ROCHE DIAGNOSTICS                 510(k) NO: K122242(TRADITIONAL)
ATTN: EDIE  EADS                  PHONE NO : 317 521 4668   
9115 HAGUE ROAD                   SE DECISION MADE: 05-DEC-12
INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
ZIMMER, INC.                      510(k) NO: K122745(TRADITIONAL)
ATTN: PAULINE A SHAND             PHONE NO : 574 372 4765   
P.O. BOX 708                      SE DECISION MADE: 05-DEC-12
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM
MATERIALISE N.V.                  510(k) NO: K121640(TRADITIONAL)
ATTN: ALEXANDRA  RAZZHIVINA       PHONE NO : 321 639 6380
15 TECHNOLOGIELAAN                SE DECISION MADE: 05-DEC-12
LEUVEN    BE 3001                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLARITY
ELEKTA LTD.                       510(k) NO: K121663(TRADITIONAL)
ATTN: GEORGE  PAPAGIANNIS         PHONE NO : 514 840 9638
2050 BLEURY, SUITE 200            SE DECISION MADE: 05-DEC-12
MONTREAL    CA H3A 2J5            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PKS BILL
GYRUS ACMI, INC.                  510(k) NO: K122605(SPECIAL)
ATTN: NEIL  KELLY                 PHONE NO : 508 804 2600   
136 TURNPIKE RD.                  SE DECISION MADE: 05-DEC-12
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CALYPSO SYSTEM
VARIAN MEDICAL SYSTEMS            510(k) NO: K123137(TRADITIONAL)
ATTN: MARCIA  PAGE                PHONE NO : 206 774 4234   
2101 FORTH AVE, SUITE 500         SE DECISION MADE: 05-DEC-12
SEATTLE WA 98121                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IGROW II HAIR GROWTH SYSTEM
APIRA SCIENCE, INC.               510(k) NO: K122248(TRADITIONAL)
ATTN: RAYMOND R BLANCHE           PHONE NO : 973 539 7444   
641 SHUNPIKE RD, STE 311          SE DECISION MADE: 05-DEC-12
CHATHAM NJ 07928                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)
OMEGA LABORATORIES, INC.          510(k) NO: K122759(TRADITIONAL)
ATTN: ROBERT J BARD               PHONE NO : 248 573 5040   
400 NORTH CLEVELAND               SE DECISION MADE: 05-DEC-12
MOGADORE OH 44260                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERIT ONE SNARE SYSTEM
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K122088(TRADITIONAL)
ATTN: MARK  MULLANEY              PHONE NO : 353 917 03761
1600 WEST MERIT PKWY.             SE DECISION MADE: 05-DEC-12
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QT GUARD PLUS ANALYSIS SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K120770(TRADITIONAL)
ATTN: KRISTIN  PABST              PHONE NO : 414 721 3104   
9900 Innovation Drive             SE DECISION MADE: 06-DEC-12
Wauwatosa WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMFORT EZ
SIMPLE DIAGNOSTICS, INC.          510(k) NO: K122787(TRADITIONAL)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 06-DEC-12
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE
EXACTECH, INC.                    510(k) NO: K121067(SPECIAL)
ATTN: LINDY  KNISELY              PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 06-DEC-12
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT
SIESTA MEDICAL, INC.              510(k) NO: K121440(TRADITIONAL)
ATTN: MICHAEL  KOLBER             PHONE NO : 408 505 6626   
101 CHURCH STREET SUITE 3         SE DECISION MADE: 06-DEC-12
LOS GATOS CA 95030                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
WESTMED, INC.                     510(k) NO: K121382(TRADITIONAL)
ATTN: R. JOHN  MCKINNON           PHONE NO : 800 724 2328   
5580 S. NOGALES HIGHWAY           SE DECISION MADE: 06-DEC-12
TUCSON AZ 85706                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPLANT BAR
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K120858(TRADITIONAL)
ATTN: KATHLEEN  DRAGOVICH         PHONE NO : 949 399 1940   
2212 DUPONT DR., ST P             SE DECISION MADE: 06-DEC-12
IRVINE CA 92612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MRJ 3300
PARAMED SRL                       510(k) NO: K122034(SPECIAL)
ATTN: LUISELLA  DEBENEDETTI       PHONE NO : 010 648 9358
CORSO F.M. PERRONE 73R            SE DECISION MADE: 06-DEC-12
GENOA    IT 16152                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
FISHER & PAYKEL HEALTHCARE, LTD.  510(k) NO: K122432(TRADITIONAL)
ATTN: ROBERT  PETRY               PHONE NO : 649 574 0123
15 MAURICE PAYKEL PLACE           SE DECISION MADE: 06-DEC-12
EAST TAMAKI    NZ 2013            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720
APEX MEDICAL CORP.                510(k) NO: K112079(TRADITIONAL)
ATTN: ALAN  CHANG                 PHONE NO : 886 222 683100
NO. 9, MINSHENG STREET            SE DECISION MADE: 06-DEC-12
TUCHENG CITY, TAIPEI COUNTY    TW 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
FRESENIUS MEDICAL CARE, NORTH AMER510(k) NO: K121341(TRADITIONAL)
ATTN: DENISE  OPPERMANN           PHONE NO : 781 699 4479   
920 WINTER STREET                 SE DECISION MADE: 06-DEC-12
WALTHAM MA 01854                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PIEZOSURGERY TOUCH
MECTRON S.P.A.                    510(k) NO: K122322(TRADITIONAL)
ATTN: ROGER  GRAY                 PHONE NO : 39 06 5782665
PIAZZA ALBANIA 10                 SE DECISION MADE: 06-DEC-12
ROME    IT 00153                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHYSIOSTAR NFC
CANDULOR USA, INC.                510(k) NO: K122852(TRADITIONAL)
ATTN: DONNA MARIE  HARTNETT       PHONE NO : 716 691 2260   
175 PINEVIEW DRIVE                SE DECISION MADE: 06-DEC-12
AMHERST NY 14228                  510(k) STATEMENT

DEVICE: PATRIOT SPACERS
GLOBUS MEDICAL, INC.              510(k) NO: K122097(SPECIAL)
ATTN: MERIAM  YOUSSEF             PHONE NO : 610 930 1800   
2560 General Armistead Ave VALLEY SE DECISION MADE: 06-DEC-12
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
SEBIA                             510(k) NO: K122101(TRADITIONAL)
ATTN: KAREN  ANDERSON             PHONE NO : 800 835 6497   
1705 CORPORATE DRIVE SUITE 400    SE DECISION MADE: 06-DEC-12
DULUTH GA 30093                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
TENSYS MEDICAL SYSTEMS, INC       510(k) NO: K123446(SPECIAL)
ATTN: JAMIE  SULLEY               PHONE NO : 858 320 3234   
5825 OBERLIN DRIVE SUITE 100      SE DECISION MADE: 07-DEC-12
SAN DIEGO CA 92121                510(k) STATEMENT

DEVICE: SAFEAIR SMOKE PENCIL,
LNA MEDICAL APS                   510(k) NO: K120454(TRADITIONAL)
ATTN: RICK  GILLIS, PH.D          PHONE NO : 512 327 9997   
611 W 5TH ST                      SE DECISION MADE: 07-DEC-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPELASER PRO II AND THE OPELASER LITE II
THE YOSHIDA DENTAL MFG. CO., LTD. 510(k) NO: K120932(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RACELLO CT                   SE DECISION MADE: 07-DEC-12
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLOOD GLUCOSE MONITORING SYSTEM
ANDON MEDICAL CO., LTD            510(k) NO: K120813(TRADITIONAL)
ATTN: YI  LIU                     PHONE NO : 862 287 612426
NO. 26 HANG YU ROAD TIANJIN AIRPORSE DECISION MADE: 07-DEC-12
TIANJIN    CH 300381              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DDRVERSA MOTION
SWISSRAY MEDICAL AG               510(k) NO: K123005(SPECIAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 07-DEC-12
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OCELOT CATHETER
AVINGER, INC.                     510(k) NO: K123462(SPECIAL)
ATTN: ALBERT  BONISKE             PHONE NO : 650 241 7004   
400 CHESAPEAKE DRIVE              SE DECISION MADE: 07-DEC-12
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ES2 SPINAL SYSTEM MODEL 48280XXXX
STRYKER SPINE                     510(k) NO: K122845(TRADITIONAL)
ATTN: SORAYA  KING                PHONE NO : 201 760 8296   
2 PEARL COURT                     SE DECISION MADE: 07-DEC-12
ALLENDALE NJ 07401                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
IDEV TECHNOLOGIES, INC.           510(k) NO: K122546(TRADITIONAL)
ATTN: DARLENE  GARNER             PHONE NO : 281 525 2000   
253 Medical Center Blvd.          SE DECISION MADE: 07-DEC-12
Webster TX 77598                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: V2F ANTERIOR FIXATION SYSTEM
ZIMMER SPINE, INC                 510(k) NO: K122733(TRADITIONAL)
ATTN: JENNIFER  TRIBBETT          PHONE NO : 512 533 1061   
5301 RIATA PARK COURT BUILDING F  SE DECISION MADE: 07-DEC-12
AUSTIN TX 78727                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNIPOD INSULIN MANAGMENT SYSTEM
INSULET CORPORATION               510(k) NO: K122953(TRADITIONAL)
ATTN: MICHAEL J DOYLE             PHONE NO : 781 457 5000   
9 OAK PARK DR.                    SE DECISION MADE: 07-DEC-12
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XTOOL
OUROBOROS MEDICAL                 510(k) NO: K122861(TRADITIONAL)
ATTN: SHELLEY  TRIMM              PHONE NO : 510 933 3441   
47757 FREMONT BLVD                SE DECISION MADE: 07-DEC-12
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM
NUVASIVE, INC.                    510(k) NO: K122742(SPECIAL)
ATTN: SHEILA  BRUSCHI             PHONE NO : 858 320 4515   
7475 LUSK BLVD                    SE DECISION MADE: 07-DEC-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PC-60NW FINGERTIP OXIMETER
SHENZHEN CREATIVE INDUSTRY CO., LT510(k) NO: K120502(ABBREVIATED)
ATTN: CHARLES  MACK               PHONE NO : 931 625 4938   
77325 JOYCE WAY                   SE DECISION MADE: 07-DEC-12
ECHO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZQUIET PRO-PLUS
SLEEPING WELL, LLC                510(k) NO: K122475(TRADITIONAL)
ATTN: DANIEL  WEBSTER             PHONE NO : 802 985 3013   
5247 Shelburne Rd Ste 204         SE DECISION MADE: 07-DEC-12
Shelburne VT 05482                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE
MEDI-KHAN USA, INC                510(k) NO: K121703(SPECIAL)
ATTN: KACHI  ENYINNA              PHONE NO : 240 994 4242   
399 MASSACHUSETTS AVE. #2         SE DECISION MADE: 07-DEC-12
BOSTON MA 02115                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG
AAP IMPLANTATE AG                 510(k) NO: K121495(TRADITIONAL)
ATTN: MARC  SEEGERS               PHONE NO : 493 075 019192
LORENZWEG 5                       SE DECISION MADE: 07-DEC-12
BERLIN    GM 12099                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVERSE MEDICAL MICROCATHETER
REVERSE MEDICAL CORPORATION       510(k) NO: K122684(TRADITIONAL)
ATTN: JEFFREY  VALKO              PHONE NO : 949 215 0660   
13700 ALTON PARKWAY SUITE 167     SE DECISION MADE: 07-DEC-12
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C)
DENTERPRISE INTERNATIONAL, INC.   510(k) NO: K122582(TRADITIONAL)
ATTN: CLAUDE  BERTHOIN            PHONE NO : 386 672 0450   
110 EAST GRANADA BLVD             SE DECISION MADE: 07-DEC-12
ORMOND BEACH FL 32176             510(k) STATEMENT

DEVICE: AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
MEDTRONIC INC.                    510(k) NO: K122760(TRADITIONAL)
ATTN: JULIA A NELSON              PHONE NO : 769 844 9672   
7611 NORTHLAND DRIVE              SE DECISION MADE: 07-DEC-12
MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE
ARJOHUNTLEIGH POLSKA SP Z.O.O.    510(k) NO: K122330(SPECIAL)
ATTN: DAVID  MOYNHAM              PHONE NO : 442 920 447084
35 PORTMANMOOR ROAD               SE DECISION MADE: 07-DEC-12
CARDIFF    UK CF24 5HN            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMI CARDIOVASCULAR PATCH
SOLINAS MEDICAL INC               510(k) NO: K122105(SPECIAL)
ATTN: JAMES  HONG                 PHONE NO : 650 793 5015   
443 COSTA MESA TERRACE            SE DECISION MADE: 07-DEC-12
SUNNY VALE CA 94089               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
HERAEUS KULZER, LLC               510(k) NO: K123278(SPECIAL)
ATTN: JAMIE  MEARNA               PHONE NO : 574 299 5421   
300 Heraeus Way                   SE DECISION MADE: 07-DEC-12
SOUTH BEND IN 46614               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RMGI LOW VISCOSITY
PULPDENT CORPORATION              510(k) NO: K123265(TRADITIONAL)
ATTN: KENNETH J BERK              PHONE NO : 617 926 6666   
80 Oakland St                     SE DECISION MADE: 07-DEC-12
WATERTOWN MA 02472                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)
TEMREX CORP.                      510(k) NO: K123273(TRADITIONAL)
ATTN: HABIB  LAFIR                PHONE NO : 516 868 6221   
300 Buffalo Ave                   SE DECISION MADE: 07-DEC-12
FREEPORT NY 11520                 510(k) STATEMENT

DEVICE: CLEARBLUE ADVANCED PREGNANCY TEST WITH WEEKS ESTIMATOR
SPD SWISS PRECISION DIAGNOSTICS GM510(k) NO: K112870(TRADITIONAL)
ATTN: LOUISE  ROBERTS             PHONE NO : 441 234 835564
PRIORY BUSINESS PARK              SE DECISION MADE: 10-DEC-12
BEDFORD    UK MK44 3UP            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMERGE MEDICAL SOLID BONE SCREWS
EMERGE MEDICAL                    510(k) NO: K122489(TRADITIONAL)
ATTN: VICTORIA  TRAFKA            PHONE NO : 303 225 7909   
790 S. COLORADO BLVD SUITE 550-S  SE DECISION MADE: 10-DEC-12
DENVER CO 80246                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K121391(TRADITIONAL)
ATTN: ARMIN  ZEHTABCHI            PHONE NO : 949 399 1940   
2212 DUPONT DR., ST P             SE DECISION MADE: 10-DEC-12
IRVINE CA 92612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDNAV
PAIEON, INC.                      510(k) NO: K120282(TRADITIONAL)
ATTN: SHIMON  VAKNIN              PHONE NO : 972 391 50000
23 HAMELACHA ST., P.O.B. 11355    SE DECISION MADE: 10-DEC-12
ROSH HAAYIN    IS 48901           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
SHANDONG HONGXIN CHEMICALS CO., LT510(k) NO: K122828(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
RM. 1606 BLDG. 1 JIANXIANG YUAN NOSE DECISION MADE: 10-DEC-12
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
YUANHANG PLASTIC CO., LTD         510(k) NO: K122835(TRADITIONAL)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441
RM. 1606 BLDG 1 JIANXIANG YUAN NO.SE DECISION MADE: 10-DEC-12
BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
NITRILIST GLOVES MANUFACTURING SDN510(k) NO: K122874(TRADITIONAL)
ATTN: LAU  SIONG  HUT             PHONE NO : 606 481 1876
PT 197, KAWASAN PERINDUSTRIAN DIOHSE DECISION MADE: 10-DEC-12
KUALA PILAH    MY 72000           510(k) STATEMENT

DEVICE: JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN
JETPREP, LTD.                     510(k) NO: K122740(SPECIAL)
ATTN: JOHN  SMITH, MD, JD         PHONE NO : 202 637 3638   
COLUMBIA SQUARE 555 13TH STREET, NSE DECISION MADE: 10-DEC-12
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM
TLELFLEX MEDICAL, INC.            510(k) NO: K120953(TRADITIONAL)
ATTN: LORRAINE  DELONG            PHONE NO : 919 361 4071   
2917 WECK DRIVE                   SE DECISION MADE: 10-DEC-12
RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OP300
PALODEX GROUP OY                  510(k) NO: K122018(SPECIAL)
ATTN: MATTI  TULIKOURA            PHONE NO : 358 102 702000
NAHKELANTIE 160                   SE DECISION MADE: 10-DEC-12
TUUSULA    FI 04300               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MTA2 ROOT AND PULP MATERIALS
AVALON BIOMED INC.                510(k) NO: K122892(TRADITIONAL)
ATTN: CAROLYN  PRIMUS             PHONE NO : 941 753 9737   
7282 55TH AVE E #227              SE DECISION MADE: 11-DEC-12
BRADENTON FL 34203                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIXALL TM WOUND AND SKIN CARE
SERIOUSLY CLEAN LTD               510(k) NO: K113693(TRADITIONAL)
ATTN: KIP  GLASS                  PHONE NO : 417 725 2116   
1075 W. KATHRYN ST. SUITE 6       SE DECISION MADE: 11-DEC-12
NIXA MO 65714                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAVRIC SL
GE MEDICAL SYSTEMS, LLC           510(k) NO: K113394(TRADITIONAL)
ATTN: YUAN  MA                    PHONE NO : 262 521 6223   
3200 N.GRANDVIEW BLVD. W-828      SE DECISION MADE: 11-DEC-12
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD
NCS LAB SRL                       510(k) NO: K120356(TRADITIONAL)
ATTN: MATTEO  MANTOVANI           PHONE NO : 390 596 69813
VIA POLA ESTERNA 4/12             SE DECISION MADE: 11-DEC-12
CARPI    IT 41012                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BPA-FREE MICROHYBID COMPOSITE
NOVOCOL, INC.                     510(k) NO: K120237(ABBREVIATED)
ATTN: CORA  BRACHO-TROCONIS       PHONE NO : 303 665 7535   
416 SOUTH TAYLOR AVE.             SE DECISION MADE: 11-DEC-12
LOUISVILLE CO 80027               510(k) STATEMENT

DEVICE: GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ
TERUMO MEDICAL CORPORATION        510(k) NO: K122980(TRADITIONAL)
ATTN: DANIEL R PLONSKI            PHONE NO : 410 392 7395   
950 ELKTON BLVD                   SE DECISION MADE: 11-DEC-12
ELKTON MD 21921                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID
KURARAY NORITAKE DENTAL INC.      510(k) NO: K122421(TRADITIONAL)
ATTN: MICHIO  TAKIGAWA            PHONE NO : 813 670 11706
OTE CENTER BLDG 7F 1-1-3, OTEMACHISE DECISION MADE: 11-DEC-12
CHIYODA-KU    JA 100-0004         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DA01 BLOOD GLUCOSE MONITORING SYSTEM
DELBIO INCORPORATION              510(k) NO: K120866(TRADITIONAL)
ATTN: NICKY  PAN                  PHONE NO : 886 335962 68
3F, NO. 252, SHANGYING ROAD GUISHASE DECISION MADE: 11-DEC-12
TAOYUAN COUNTY    TW 33341        510(k) STATEMENT

DEVICE: QUARK SERIES
COSMED S.R.L.                     510(k) NO: K120146(TRADITIONAL)
ATTN: ROBERT  SCHIFF              PHONE NO : 973 227 1830   
1129 BLOOMFIELD AVENUE            SE DECISION MADE: 11-DEC-12
WEST CALDWELL NJ 07000            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
SOFRADIM PRODUCTION               510(k) NO: K123479(SPECIAL)
ATTN: JAMES  MCMAHON              PHONE NO : 508 452 1545   
15 CROSBY DRIVE                   SE DECISION MADE: 11-DEC-12
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOSCOPE
PULSECOR LIMITED                  510(k) NO: K121266(TRADITIONAL)
ATTN: E.J.  SMITH                 PHONE NO : 888 729 9674   
1468 HARWELL AVE.                 SE DECISION MADE: 11-DEC-12
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASONIC SURGERY
DMETEC CO., LTD.                  510(k) NO: K121620(TRADITIONAL)
ATTN: DANIEL  NAM                 PHONE NO : 213 626 1544   
4568 W. 1ST STREET SUITE 104      SE DECISION MADE: 11-DEC-12
LOS ANGELES CA 90004              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K123317(SPECIAL)
ATTN: SHERI L MUSGNUNG            PHONE NO : 484 896 3147   
3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 11-DEC-12
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NP-CAST ABUTMENT SYSTEM
OSSTEM IMPLANT CO.,LTD            510(k) NO: K121843(TRADITIONAL)
ATTN: PATRICK  LIM                PHONE NO : 888 678 0001   
85 BEN FAIRLESS DR                SE DECISION MADE: 11-DEC-12
FAIRLESS HILLS PA 19030           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS
DENTSPLY INTERNATIONAL            510(k) NO: K122268(TRADITIONAL)
ATTN: HELEN  LEWIS                PHONE NO : 717 849 4229   
SUSQUEHANNA COMMERCE CTR. WEST 221SE DECISION MADE: 11-DEC-12
YORK PA 17404                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PBP TOTAL HIP SYSTEM
PIPELINE BIOMEDICAL PRODUCTS, LLC 510(k) NO: K122158(TRADITIONAL)
ATTN: TERRY  POWELL               PHONE NO : 703 562 9800   
901 KING STREET SUITE 200         SE DECISION MADE: 11-DEC-12
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: L.A.M. IMP WOUND GEL
GLYCOBIOSCIENCES, INC             510(k) NO: K123113(TRADITIONAL)
ATTN: JAMES  JOHNSON              PHONE NO : 905 271270 9
181 LAKESHORE ROAD EAST           SE DECISION MADE: 11-DEC-12
MISSISSAUGA, ONTARIO    CA L5G 1G2510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMBIENT TURBOFLASH 90 IFS
ARTHOCARE CORPORATION             510(k) NO: K120791(SPECIAL)
ATTN: CHERYL  FREDERICK           PHONE NO : 512 358 5751   
7000 WEST WILLIAM CANNON DRIVE BUISE DECISION MADE: 11-DEC-12
AUSTIN TX 78735                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM
BEIJING SYNTECH LASER CO., LTD.   510(k) NO: K113018(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 212 2815850
P.O. BOX 237-023                  SE DECISION MADE: 12-DEC-12
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE
STERITEC PRODUCTS MFG. CO., INC.  510(k) NO: K122555(ABBREVIATED)
ATTN: JONATHAN  RUTIGLIANO        PHONE NO : 303 660 4201   
74 INVERNESS DRIVE EAST           SE DECISION MADE: 12-DEC-12
ENGLEWOOD CO 80112                510(k) STATEMENT

DEVICE: MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
SEASPINE, INC.                    510(k) NO: K122571(SPECIAL)
ATTN: ETHEL  BERNAL               PHONE NO : 760 727 8399   
2302 la Mirada Dr                 SE DECISION MADE: 12-DEC-12
VISTA CA 92081                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOSAIQ ONCOLOGY INFORMATION SYSTEM
IMPAC MEDICAL SYSTEMS, INC.       510(k) NO: K123230(TRADITIONAL)
ATTN: KATHRYN  STINSON            PHONE NO : 314 993 0003   
100 MATHILDA PLACE, 5TH FLOOR     SE DECISION MADE: 12-DEC-12
SUNNYVALE CA 94086                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
SOFLEX LIMITED                    510(k) NO: K122213(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
33 GOLDEN EAGLE LANE              SE DECISION MADE: 12-DEC-12
LITTLETON CO 80127                510(k) STATEMENT

DEVICE: VASU-PICC
MEDICAL COMPONENTS INC            510(k) NO: K122423(TRADITIONAL)
ATTN: JESSICA  LEO                PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 12-DEC-12
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS
STRAUMANN USA                     510(k) NO: K122855(TRADITIONAL)
ATTN: ELAINE  ALAN                PHONE NO : 978 747 2513   
60 MINUTEMAN ROAD                 SE DECISION MADE: 12-DEC-12
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER
CHANGZHOU HOLYMED PRODUCTS CO LTD 510(k) NO: K122000(TRADITIONAL)
ATTN: ALAN  YU                    PHONE NO : 865 198 6465969
528 CHANGWU ROAD SOUTH WUJIN DISTRSE DECISION MADE: 12-DEC-12
CHANGHOU    CH 213167             510(k) STATEMENT

DEVICE: S4 SPINAL SYSTEM
AESCULAP IMPLANT SYSTEMS, INC.    510(k) NO: K123352(TRADITIONAL)
ATTN: LISA M BOYLE                PHONE NO : 610 984 9274   
3773 CORPORATE PWKY.              SE DECISION MADE: 12-DEC-12
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LENSX LASER SYSTEM
ALCON LENSX, INC.                 510(k) NO: K123120(TRADITIONAL)
ATTN: JUDY  GORDON, DVM           PHONE NO : 949 715 0609   
733 BOLSANA DRIVE                 SE DECISION MADE: 12-DEC-12
LAGUNA BEACH CA 92651             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
AXIS-SHIELD DIAGNOSTICS, LTD.     510(k) NO: K121842(TRADITIONAL)
ATTN: CLAIRE I DORA               PHONE NO : 44 13 82422000
THE TECHNOLOGY PARK               SE DECISION MADE: 12-DEC-12
DUNDEE, SCOTLAND    UK DD2 1XA    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
FOTONA D.D.                       510(k) NO: K121508(TRADITIONAL)
ATTN: STOJAN  TOST                PHONE NO : 386 150 09100
STEGNE 7,                         SE DECISION MADE: 12-DEC-12
LJUBLJANA    SI 1210              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VSP SYSTEM
MEDICAL MODELING INC              510(k) NO: K120956(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637 5794   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 12-DEC-12
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGICAL GOWN, SMS
JIANGSU GUANGDA MEDICAL MATERIAL, 510(k) NO: K121152(ABBREVIATED)
ATTN: DARREN  REEVES              PHONE NO : 804 307 7706   
7305 HANCOCK VILLAGE DR SUITE 109 SE DECISION MADE: 12-DEC-12
CHESTERFIELD VA 23832             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIGATOR HD URETERAL ACCESS SHEATH SET
BOSTON SCIENTIFIC CORP.           510(k) NO: K122649(TRADITIONAL)
ATTN: HUDA  YUSUF                 PHONE NO : 508 683 4216   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 12-DEC-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYOTOP
KITAZATO BIOPHARMA CO;LTD         510(k) NO: K112695(TRADITIONAL)
ATTN: RICHARD  VINCINS CQA,RAC(US,PHONE NO : 512 327 9997   
611 WEST 5TH ST                   SE DECISION MADE: 12-DEC-12
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE
MEDTRONIC INC.                    510(k) NO: K123448(SPECIAL)
ATTN: JULIA A NELSON              PHONE NO : 763 514 9844   
7611 NORTHLAND DRIVE              SE DECISION MADE: 13-DEC-12
MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIGNAL GEAR URETHRAL CATHETER ELECTRODE
NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K113771(TRADITIONAL)
ATTN: CHRISTINE  VERGELY          PHONE NO : 805 866 6999   
2225 Sperry Ave Suite 1000        SE DECISION MADE: 13-DEC-12
VENTURA CA 93003                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
PHILIPS MEDICAL SYSTEMS           510(k) NO: K123492(SPECIAL)
ATTN: LISA  SIMPSON               PHONE NO : 352 336 0010   
3545 S W 47TH AVENUE              SE DECISION MADE: 13-DEC-12
GAINESVILLE FL 32608 1099         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K122535(TRADITIONAL)
ATTN:                             PHONE NO : 
10 HIGH POINT DRIVE               SE DECISION MADE: 13-DEC-12
WAYNE NJ 07470                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PRESTO 1000 SYSTEM
PHYSIOSONICS, INC                 510(k) NO: K123565(TRADITIONAL)
ATTN: DAVID  CRONISER             PHONE NO : 425 732 2814   
2002 156TH AVE, NE, SUITE 150 MCKISE DECISION MADE: 13-DEC-12
BELLEVUE WA 98007                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VEX-S 100W INTRAORAL X-RAY SYSTEM
VATECH CO., LTD.                  510(k) NO: K123493(SPECIAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 13-DEC-12
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELLTRACKS AUTOPREP SYSTEM
VERIDEX, LLC                      510(k) NO: K122821(SPECIAL)
ATTN: KIMBERLY  PRESCOTT          PHONE NO : 908 927 4947   
1001 US HIGHWAY 202 NORTH         SE DECISION MADE: 13-DEC-12
RARITAN NJ 08869 0606             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
MICROGENICS CORPORATION           510(k) NO: K120936(ABBREVIATED)
ATTN: KAREN  LEE                  PHONE NO : 510 979 5000   
46360 FREMONT BLVD.               SE DECISION MADE: 13-DEC-12
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
GUIDEPATH MEDICAL, INC.           510(k) NO: K121398(TRADITIONAL)
ATTN: JOHN  MITCHELL TATUM        PHONE NO : 512 638 2000   
2621 RIDGEPOINT DR. STE 100       SE DECISION MADE: 13-DEC-12
AUSTIN TX 78754                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K122613(TRADITIONAL)
ATTN: CHARLEMAGNE  CHUA           PHONE NO : 714 730 5000   
2441 MICHELLE DR.                 SE DECISION MADE: 13-DEC-12
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K122459(ABBREVIATED)
ATTN: MICHELLE  BERRY             PHONE NO : 508 683 4941   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 13-DEC-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZOLL SUREPOWER SINGLE BAY CHARGER
ZOLL MEDICAL CORPORATION          510(k) NO: K122839(SPECIAL)
ATTN: TANMAY B SHUKLA             PHONE NO : 978 421 9171   
269 MILL ROAD                     SE DECISION MADE: 13-DEC-12
CHELMSFORD MA 01824               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K123503(TRADITIONAL)
ATTN: BAI  YANHONG                PHONE NO : 86 755 81885635
MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 13-DEC-12
SHENZHEN    CH 518057             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
OSCOR INC.                        510(k) NO: K122958(TRADITIONAL)
ATTN: MILA  DOSKOCIL              PHONE NO : 727 937 2511   
3816 DE SOTO BLVD.                SE DECISION MADE: 13-DEC-12
PALM HARBOR FL 34683              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
OSCOR INC.                        510(k) NO: K122960(TRADITIONAL)
ATTN: MILA  DOSKOCIL              PHONE NO : 727 937 2511   
3816 DE SOTO BLVD.                SE DECISION MADE: 13-DEC-12
PALM HARBOR FL 34683              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHODONTIC CERAMIC BRACKETS
TOMY, INC.                        510(k) NO: K123094(TRADITIONAL)
ATTN: CAROLYN  PRIMUS             PHONE NO : 941 753 9737   
7046 OWL'S NEST TERRACE           SE DECISION MADE: 13-DEC-12
BRADENTON FL 34203                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMPLIVUE C. DIFFICILE ASSAY
QUIDEL CORPORATION                510(k) NO: K123355(TRADITIONAL)
ATTN: RONALD H LOLLAR             PHONE NO : 858 552 1100   
10165 MCKELLAR COURT              SE DECISION MADE: 13-DEC-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,
ANDREW TECHNOLOGIES, LLC          510(k) NO: K121218(SPECIAL)
ATTN: HERBERT  CRANE              PHONE NO : 949 502 1907   
3 Haddon Avenue                   SE DECISION MADE: 13-DEC-12
Haddonfield NJ 08033              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MILAGRO INTERFERENCE SCREWS
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K122869(TRADITIONAL)
ATTN: KRISTINE  CHRISTO           PHONE NO : 508 828 3359   
325 PARAMOUNT DR.                 SE DECISION MADE: 13-DEC-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GORE FLOW REVERSAL SYSTEM MODEL GFRS073
W. L. GORE & ASSOCIATES, INC.     510(k) NO: K123156(SPECIAL)
ATTN: SHARON  ALEXANDER           PHONE NO : 623 234 5440   
32360 N NORTH VALLEY PARKWAY      SE DECISION MADE: 13-DEC-12
PHOENIX AZ 85085                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
DEFIBTECH, LLC                    510(k) NO: K121853(TRADITIONAL)
ATTN: ED  HORTON                  PHONE NO : 203 453 6654   
741 BOSTON POST ROAD              SE DECISION MADE: 13-DEC-12
GUILFORD CT 06437                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENAMIC
VITA ZAHNFABRIK H. RAUTER GMBH & C510(k) NO: K122269(ABBREVIATED)
ATTN: ELIZABETH  WOLFSEN          PHONE NO : 714 961 6200   
3150 EAST BIRCH STREET            SE DECISION MADE: 13-DEC-12
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINX SURGICAL MESH
MEDLINX ACALA PTE LTD             510(k) NO: K120844(TRADITIONAL)
ATTN: STEPHEN P RHODES            PHONE NO : 301 579 3700   
3502 DUNDEE DRIVE                 SE DECISION MADE: 13-DEC-12
CHEVY CHASE MD 20815              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONELOG IMPLANT SYSTEM
ALTATEC GMBH                      510(k) NO: K113779(TRADITIONAL)
ATTN: LINDA  SCHULZ               PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 14-DEC-12
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COUGHASSIST T70 DEVICE
RESPIRONICS, INC.                 510(k) NO: K121955(TRADITIONAL)
ATTN: COLLEEN  WITT               PHONE NO : 724 387 4870   
1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 14-DEC-12
MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASCENDX VCF REDUCTION SYSTEM
AOI MEDICAL, INC.                 510(k) NO: K100404(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET STREET 29TH FLOOR     SE DECISION MADE: 14-DEC-12
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLIADIN IGA AND GLIADIN LGA
GRIFOLS USA, LLC                  510(k) NO: K113377(TRADITIONAL)
ATTN: CATHERINE L WONG            PHONE NO : 323 227 7280   
2410 LILLYVALE AVE.               SE DECISION MADE: 14-DEC-12
LOS ANGELES CA 90032              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOLECULAR ADSORBENT RECIRCULATING(MARS)
GAMBRO RENAL PRODUCTS, INC.       510(k) NO: K113313(TRADITIONAL)
ATTN: KAE  MILLER                 PHONE NO : 303 222 6724   
14143 DENVER WEST PARKWAY SUITE 40SE DECISION MADE: 14-DEC-12
LAKEWOOD CO 80401                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDILAS H LASER FIBERS
DORNIER MEDTECH AMERICA, INC.     510(k) NO: K123385(SPECIAL)
ATTN: JOHN  HOFFER                PHONE NO : 770 514 6163   
1155 ROBERTS BLVD.                SE DECISION MADE: 14-DEC-12
KENNESAW GA 30144                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OCELOT PIXL CATHETER
AVINGER, INC.                     510(k) NO: K123532(SPECIAL)
ATTN: BABU  PERIASAMY             PHONE NO : 650 241 7004   
400 CHESAPEAKE DRIVE              SE DECISION MADE: 14-DEC-12
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)
COOK, INC.                        510(k) NO: K122937(SPECIAL)
ATTN: AMBER  BROWN                PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 14-DEC-12
Blmgtn IN 47404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAXLOCK EXTREME SYSTEM MODEL MXL
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K123203(TRADITIONAL)
ATTN: DEREK  LEWIS                PHONE NO : 330 869 9562   
1065 Medina Rd. SUITE 500         SE DECISION MADE: 14-DEC-12
Medina OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811
MEDTRONIC INC.                    510(k) NO: K122827(TRADITIONAL)
ATTN: MARY E DONLIN               PHONE NO : 763 526 9172   
7611 NORTHLAND DRIVE              SE DECISION MADE: 14-DEC-12
MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K122840(TRADITIONAL)
ATTN: CHUCK  SMITH                PHONE NO : 914 667 3999   
521 HOMESTEAD AVE.                SE DECISION MADE: 14-DEC-12
MOUNT VERNON NY 10550             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIDEO SYSTEM CENTER
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K122831(TRADITIONAL)
ATTN: SHERI L MUSGNUNG            PHONE NO : 484 896 3147   
3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 14-DEC-12
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GYRUS ACMI BICOAG HEMOSTASIS PROBE
OLYMPUS SURGICAL TECHNOLOGIES AMER510(k) NO: K123319(SPECIAL)
ATTN: NEIL  KELLY                 PHONE NO : 508 804 2600   
136 TURNPIKE ROAD                 SE DECISION MADE: 14-DEC-12
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OXTI INFLATION DEVICE
OXTI CORPORATION                  510(k) NO: K122152(TRADITIONAL)
ATTN: JOSEPH J CHANG              PHONE NO : 832 545 8399   
7128 STAFFORDSHIRE STREET         SE DECISION MADE: 14-DEC-12
HOUSTON TX 77030                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIPAP A 40 VENTILATORY SUPPORT SYSTEM
RESPIRONICS, INC.                 510(k) NO: K121623(ABBREVIATED)
ATTN: ELAINE  LARKIN              PHONE NO : 724 387 5350   
1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 14-DEC-12
MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNBALLOON NON-OCCLUSIVE MODELING CATHETER
LEMAITRE VASCULAR, INC.           510(k) NO: K123531(SPECIAL)
ATTN: BRYAN  COWELL, RAC          PHONE NO : 781 221 2266   
63 SECOND AVENUE                  SE DECISION MADE: 14-DEC-12
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NDX ABUTMENTS
NATIONAL DENTEX CORP              510(k) NO: K121117(TRADITIONAL)
ATTN: LINDA K SCHULZ              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 14-DEC-12
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMPOWER CLEAR
AMERICAN ORTHODONTICS             510(k) NO: K122753(TRADITIONAL)
ATTN: TRANG  ADAMS                PHONE NO : 920 457 5051   
1536 N. 18TH ST.                  SE DECISION MADE: 14-DEC-12
SHEBOYGAN WI 53081                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
CORELINK LLC                      510(k) NO: K121514(TRADITIONAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   
1331 H STREET 12TH FLOOR          SE DECISION MADE: 14-DEC-12
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERCUNAV
PHILIPS HEALTHCARE                510(k) NO: K121498(TRADITIONAL)
ATTN: TARA  MACKINNON             PHONE NO : 416 603 8349
49 SPADINA AVENUE #310            SE DECISION MADE: 14-DEC-12
TORONTO    CA M5V 2J1             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMVERA DIOLUX
EMVERA TECHNOLOGIES, INC.         510(k) NO: K123257(TRADITIONAL)
ATTN:                             PHONE NO : 
1468 HARWELL AVE.                 SE DECISION MADE: 14-DEC-12
CROFTON MD 21114                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CATHETER CONNECTIONS DUALCAP SOLO
CATHETER CONNECTIONS, INC.        510(k) NO: K123065(SPECIAL)
ATTN: DONALD D SOLOMON            PHONE NO : 801 209 1269   
615 Arapeen Dr Ste 302A           SE DECISION MADE: 14-DEC-12
Salt Lake City UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
ACON LABORATORIES, INC.           510(k) NO: K123010(TRADITIONAL)
ATTN: XIE  QIYI                   PHONE NO : 858 875 8011   
10125 Mesa Rim Road               SE DECISION MADE: 14-DEC-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
VENTANA MEDICAL SYSTEMS, INC.     510(k) NO: K110215(TRADITIONAL)
ATTN: ROXANE  BONNER              PHONE NO : 520 229 4388   
1910 EAST INNOVATION PARK DR.     SE DECISION MADE: 17-DEC-12
TUCSON AZ 85755                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LACRIFAST
HIROYASU HIGUCHI                  510(k) NO: K120886(TRADITIONAL)
ATTN: FUMIAKI  KANAI, PH.D.       PHONE NO : 011 81 338188577
4-1 17 HONGO, BUNKYO-KU           SE DECISION MADE: 17-DEC-12
TOKYO    JA 113-0033              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALPHA CRYPTOCOCCAL ANTIGEN EIA
IMMUNO-MYCOLOGICS, INC.           510(k) NO: K120946(TRADITIONAL)
ATTN: SEAN K BAUMAN               PHONE NO : 405 360 4669   
2700 TECHNOLOGY PLACE             SE DECISION MADE: 17-DEC-12
NORMAN OK 73071                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERTIFLEX SPINOUS PROCESS FIXATION PLATE
VERTIFLEX, INC.                   510(k) NO: K122509(TRADITIONAL)
ATTN: STEVE  REITZLER             PHONE NO : 949 940 1434   
1351 CALLE AVANZADO               SE DECISION MADE: 17-DEC-12
SAN CLAMENTE CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM
AESCULAP IMPLANT SYSTEMS, LLC     510(k) NO: K120955(TRADITIONAL)
ATTN: KATHY A RACOSKY             PHONE NO : 610 984 9291   
3773 CORPORATE PARKWAY            SE DECISION MADE: 17-DEC-12
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
SYNTHES SPINE                     510(k) NO: K122211(TRADITIONAL)
ATTN: HEMAL  MEHTA                PHONE NO : 610 719 5424   
1302 WRIGHTS LN EAST              SE DECISION MADE: 17-DEC-12
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVOLUTION 3E VENTILATOR
EVENT MEDICAL, INC.               510(k) NO: K113743(TRADITIONAL)
ATTN: RICK  WATERS                PHONE NO : 949 492 8312   
971 CALLE AMANECER SUITE 101      SE DECISION MADE: 18-DEC-12
SAN CLEMENTE CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
COLOPLAST CORP.                   510(k) NO: K122968(TRADITIONAL)
ATTN: MARGARET  BATCHELEDER       PHONE NO : 612 344 2334   
1601 WEST RIVER N                 SE DECISION MADE: 18-DEC-12
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER
COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K123318(SPECIAL)
ATTN: SARAH  RIZK                 PHONE NO : 203 492 5493   
60 Middletown Ave                 SE DECISION MADE: 18-DEC-12
North Haven CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS
BSN MEDICAL, INC.                 510(k) NO: K123561(SPECIAL)
ATTN: CARROLL D HOYLE             PHONE NO : 828 879 5100   
100 BEIERSDORF DRIVE              SE DECISION MADE: 18-DEC-12
RUTHERFORD COLLEGE NC 28671       510(k) STATEMENT

DEVICE: LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
GE HEALTHCARE                     510(k) NO: K123564(SPECIAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE             SE DECISION MADE: 18-DEC-12
WAUWATOSA WI 53226                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUTRISAFE 2 FEEDING TUBE
VYGON CORP.                       510(k) NO: K121105(TRADITIONAL)
ATTN: JILLIAN  MIKOVICH           PHONE NO : 800 473 5414   
103A PARK ROAD                    SE DECISION MADE: 18-DEC-12
MONTGOMERYVILLE PA 18936          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DR. SCHOLL'S COMPRESSION SOCKS
RENFRO CORPORATION                510(k) NO: K123398(TRADITIONAL)
ATTN: REBECCA K PINE              PHONE NO : 760 809 5178   
661 LINVILLE ROAD                 SE DECISION MADE: 18-DEC-12
MOUNT AIRY NC 27030               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HERMES MEDICAL IMAGING SUITE V5.2
HERMES MEDICAL SOLUTIONS, AB      510(k) NO: K121278(SPECIAL)
ATTN: JOAKIM  ARWIDSON            PHONE NO : 468 190 325
SKEPPSBRON 44                     SE DECISION MADE: 18-DEC-12
STOCKHOLM    SW 111 30            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERTEX RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K123568(SPECIAL)
ATTN: MIKE  SCOTT                 PHONE NO : 800 876 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 18-DEC-12
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRAUS SIP10
SAESHIN PRECISION CO., LTD.       510(k) NO: K123695(TRADITIONAL)
ATTN: Y.S.  LEE                   PHONE NO : 82 535 872345
#93-15, PAHO-DONG, DALSEO-GU      SE DECISION MADE: 18-DEC-12
DAEGU    KS 704-220               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
CINCINNATI SUB-ZERO PRODUCTS, INC.510(k) NO: K122813(TRADITIONAL)
ATTN: STEVEN J BERKE              PHONE NO : 513 772 8810   
12011 MOSTELLER RD.               SE DECISION MADE: 18-DEC-12
CINCINNATI OH 45241               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UPSYLON Y MESH
BOSTON SCIENTIFIC CORP.           510(k) NO: K122794(TRADITIONAL)
ATTN: LAUREN  ANDERSON            PHONE NO : 508 683 4707   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 18-DEC-12
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AESCULAP NOVOSYN ABSORBABLE SUTURE
AESCULAP, INC.                    510(k) NO: K122734(TRADITIONAL)
ATTN: KATHY A RACOSKY             PHONE NO : 610 984 9291   
3773 CORPORATE PARKWAY            SE DECISION MADE: 18-DEC-12
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORICARE L2700
ORICARE, INC.                     510(k) NO: K122875(TRADITIONAL)
ATTN: DAVID T JAMISON             PHONE NO : 215 538 2470   
1900 AM DRIVE                     SE DECISION MADE: 18-DEC-12
QUAKERTOWN PA 18951               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IND ONE STEP OCCULT BLOOD (FOB) TEST
IND DIAGNOSTICS INC.              510(k) NO: K113506(SPECIAL)
ATTN: KAI  LOU                    PHONE NO : 604 522 1619
1629 FOSTERS WAY                  SE DECISION MADE: 19-DEC-12
DELTA, BRITISH COLUMBIA    CA V3M 510(k) STATEMENT

DEVICE: OVS1 VIDEO SYSTEM
OLIVE MEDICAL CORP.               510(k) NO: K123359(TRADITIONAL)
ATTN: BRIAN  DEAN                 PHONE NO : 801 953 0559   
2302 Presidents Dr Ste D          SE DECISION MADE: 19-DEC-12
Salt Lake City UT 84120           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
KIMBERLY-CLARK CORP.              510(k) NO: K120985(ABBREVIATED)
ATTN: MARCIA  JOHNSON             PHONE NO : 770 587 8566   
1400 HOLCOMB BRIDGE RD.           SE DECISION MADE: 19-DEC-12
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CINCHER-2.6 SUTURE ANCHOR MODEL FG-001
FOUNDRY NEWCO XI, INC.            510(k) NO: K122954(TRADITIONAL)
ATTN: MICHAEL  KOLBER             PHONE NO : 408 505 6626   
14734 LA RINCONADA DRIVE          SE DECISION MADE: 19-DEC-12
LOS GATOS CA 95032                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOBICATH TRANSSEPTAL NEEDLE
GREATBATCH MEDICAL                510(k) NO: K122832(SPECIAL)
ATTN: DENISE  THOMPSON            PHONE NO : 763 951 8254   
2300 BERKSHIRE LANE NORTH         SE DECISION MADE: 19-DEC-12
MINNEAPOLIS MN 55441              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONTEX AND OTHER PROPRIETARY NAMES
ONTEX BVBA                        510(k) NO: K122603(TRADITIONAL)
ATTN: ROBERT J STAAB              PHONE NO : 860 434 5872   
30 NECK ROAD                      SE DECISION MADE: 19-DEC-12
OLD LYME CT 06371                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR
IBRAMED EQUIPAMENTOS MEDICOS      510(k) NO: K121369(TRADITIONAL)
ATTN: LILIAN  LLULL               PHONE NO : 305 206 6777   
18851 NE 29TH AVE 720             SE DECISION MADE: 19-DEC-12
AVENTURA FL 33180                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HELIO
MOTION COMPOSITES                 510(k) NO: K120628(TRADITIONAL)
ATTN: VINCENT  LECUYER            PHONE NO : 450 588 6555
519 J-OSWALD-FOREST SUITE 101     SE DECISION MADE: 19-DEC-12
SAINT-ROCH-DE-L' ACHIGAN    CA J06510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERTUS 140 2.45GHZ ABLATION SYSTEM
NEUWAVE MEDICAL, INC              510(k) NO: K122217(TRADITIONAL)
ATTN: DAN  KOSEDNAR               PHONE NO : 608 512 1592   
3529 ANDERSON STREET              SE DECISION MADE: 19-DEC-12
MADISON WI 53704                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRAVASCULAR ADMINISTRATION SET
ACTA MEDICAL LLC                  510(k) NO: K121803(ABBREVIATED)
ATTN: JOHN  BREWER                PHONE NO : 908 399 0279   
15 MINNEAKONING RD. SUITE 203     SE DECISION MADE: 19-DEC-12
FLEMINGTON NJ 08822               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FINN CHAMBERS AQUA
SMART PRACTICE                    510(k) NO: K123184(TRADITIONAL)
ATTN: KIM  SULLIVAN               PHONE NO : 602 225 0595   
3400 EAST MCDOWELL RD.            SE DECISION MADE: 19-DEC-12
PHOENIX AZ 85008                  510(k) STATEMENT

DEVICE: PMT TRUSCAN SURFACE ELECTRODE
PMT CORP.                         510(k) NO: K122376(TRADITIONAL)
ATTN: AL  IVERSEN                 PHONE NO : 952 470 0866   
PO Box 610                        SE DECISION MADE: 19-DEC-12
CHANHASSEN MN 55317               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BASIXCONPAK ANALOG INFLATION SYRINGE
MERIT MEDICAL IRELAND, LTD.       510(k) NO: K122321(TRADITIONAL)
ATTN: STEPHANIE  ERSKINE          PHONE NO : 801 208 4349   
1600 WEST MERIT PARKWAY           SE DECISION MADE: 19-DEC-12
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
LOTUS BIO LTD                     510(k) NO: K112644(TRADITIONAL)
ATTN: LORI  KAHLER                PHONE NO : 401 722 1811   
461 MAIN STREET SUITE 217         SE DECISION MADE: 19-DEC-12
PAWTUCKET RI 02860                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTEC DENTAL IMPLANT
SYNTEC SCIENTIFIC CORP.           510(k) NO: K111189(TRADITIONAL)
ATTN: CHIA-CHING  LEE             PHONE NO : 886 227 787396
3F1. 96 CHUNG HSIAO E. RD. SEC. 3 SE DECISION MADE: 20-DEC-12
TAIPEI CITY    TW 106             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CURASAN OSSEOLIVE DENTAL
CURASAN AG                        510(k) NO: K111105(ABBREVIATED)
ATTN: ROGER  GRAY                 PHONE NO : 390 657 82665
PIAZZA ALBANIA 10                 SE DECISION MADE: 20-DEC-12
ROME    IT 00153                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOPE REPROCESSOR OER-MINI
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K120357(TRADITIONAL)
ATTN: LAURA  STORMS-TYLER         PHONE NO : 484 896 5688   
3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 20-DEC-12
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009
FEMASYS INC.                      510(k) NO: K122658(TRADITIONAL)
ATTN: LISA  PEACOCK               PHONE NO : 770 500 3910   
5000 Research Court Suite 100     SE DECISION MADE: 20-DEC-12
Suwanee GA 30024                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INVENDO C25 COLONOSCOPY SYSTEM
INVENDO MEDICAL GBMH              510(k) NO: K121582(SPECIAL)
ATTN: OLIVER V RUEPPRECHT         PHONE NO : 498 233744 9816
PETERHOFSTR. 3B                   SE DECISION MADE: 20-DEC-12
KISSING    GM 86438               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUEBEAM
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K123291(TRADITIONAL)
ATTN: VY  TRAN                    PHONE NO : 650 424 6643   
3100 HANSEN WAY                   SE DECISION MADE: 20-DEC-12
PALO ALTO CA 94304                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K121046(TRADITIONAL)
ATTN: HEATHER  VIELE              PHONE NO : 208 377 4800   
170 S. Seneca Springs Way Suite 10SE DECISION MADE: 20-DEC-12
Star ID 83669                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
DIAMOND DIAGNOSTICS, INC          510(k) NO: K121027(TRADITIONAL)
ATTN: KATHY  CRUZ                 PHONE NO : 508 429 0450   
333 Fiske St                      SE DECISION MADE: 20-DEC-12
Holliston MA 01746                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GKS PRIME FLEX CR TOTAL KNEE SYSTEM
PERMEDICA                         510(k) NO: K122975(TRADITIONAL)
ATTN: NATALIE J KENNEL            PHONE NO : 858 705 0350   
13721 VIA TRES VISTA              SE DECISION MADE: 20-DEC-12
SAN DIEGO CA 92129                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEALTHVIEW ECG MANAGER
LUMEDX                            510(k) NO: K123466(TRADITIONAL)
ATTN: CHRIS  PEARCE               PHONE NO : 425 818 2312   
110 110TH AVE NE SUITE 475        SE DECISION MADE: 20-DEC-12
Bellevue WA 98004                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
CONFORMIS, INC.                   510(k) NO: K122991(TRADITIONAL)
ATTN: AMITA  SHAH                 PHONE NO : 781 345 9146   
11 NORTH AVENUE                   SE DECISION MADE: 20-DEC-12
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K123046(TRADITIONAL)
ATTN: NEIL  PARKER                PHONE NO : 914 524 2477   
511 BENEDICT AVE.                 SE DECISION MADE: 20-DEC-12
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO, CT CARDIAC FUNCTION
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123585(SPECIAL)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 448 4912   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 20-DEC-12
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER
STRYKER SUSTAINABILITY SOLUTIONS, 510(k) NO: K121913(TRADITIONAL)
ATTN: MOIRA  BARTON-VARTY         PHONE NO : 888 888 3433   
1810 W Drake Dr                   SE DECISION MADE: 20-DEC-12
Tempe AZ 85283                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AERODR SYSTEM, AEROSYNC FOR AERODR SYSTEM
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K123499(TRADITIONAL)
ATTN: RUSSELL  MUNVES             PHONE NO : 212 497 8208   
140 EAST 45TH ST., 25TH FLOOR TWO SE DECISION MADE: 20-DEC-12
NEW YORK NY 10017                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)
ACTUATED MEDICAL, INC.            510(k) NO: K123659(SPECIAL)
ATTN: DEBORA  DEMERS, PHD         PHONE NO : 814 355 0003   
310 Rolling Ridge Dr              SE DECISION MADE: 20-DEC-12
Bellefonte PA 16823               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED
CHANGZHOU HOLYMED PRODUCTS CO LTD 510(k) NO: K121998(TRADITIONAL)
ATTN: ALAN  YU                    PHONE NO : 865 198 6465969
528 CHANGWU ROAD SOUTH WUJIN DISTRSE DECISION MADE: 20-DEC-12
CHANGHOU    CH 213167             510(k) STATEMENT

DEVICE: OXICARE FINGERTIP PULSE OXIMETER
DELBIO INCORPORATED               510(k) NO: K122927(TRADITIONAL)
ATTN: NICKY  PAN                  PHONE NO : 886 335962 68
3F & 6F, NO 252 SHANGYING ROAD TAOSE DECISION MADE: 20-DEC-12
GUISHAN INDUSTRIAL ZONE    TW 3334510(k) STATEMENT

DEVICE: WANDY DISPERSVIE ELECTRODE
BIO-MED USA INC.                  510(k) NO: K121268(TRADITIONAL)
ATTN: YOUNG  CHI                  PHONE NO : 973 278 5222   
111 ELLISON STREET                SE DECISION MADE: 20-DEC-12
PATERSON NJ 07505                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
HOLOGIC, INC.                     510(k) NO: K123530(TRADITIONAL)
ATTN: GAIL  YAEKER-DAUNIS         PHONE NO : 203 731 8337   
36 APPLE RIDGE ROAD               SE DECISION MADE: 20-DEC-12
DANBURY CT 06810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SCENIUM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123528(SPECIAL)
ATTN: ELAINE  CHANG               PHONE NO : 865 218 2873   
810 INNOVATION DRIVE              SE DECISION MADE: 20-DEC-12
KNOXVILLE TN 37932                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AP 72OS SEMI-AUTOMATED INSTRUMENT
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K112910(TRADITIONAL)
ATTN: DONALD  POSTEL              PHONE NO : 650 961 5501   
630 CLYDE COURT                   SE DECISION MADE: 20-DEC-12
MOUNTAIN VIEW CA 94043            510(k) STATEMENT

DEVICE: STABILINK MIS SPINAL FIXATION SYSTEM
SOUTHERN SPINE, LLC               510(k) NO: K123093(TRADITIONAL)
ATTN: JULIE  STEPHENS             PHONE NO : 678 513 0693   
111 LAUREL RIDGE DRIVE            SE DECISION MADE: 20-DEC-12
ALPHARETTA GA 31201               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PANOPTIC
WELCH ALLYN, INC.                 510(k) NO: K121405(TRADITIONAL)
ATTN: KEVIN  CROSSEN              PHONE NO : 315 685 2609   
4341 STATE ST. RD. PO BOX 220     SE DECISION MADE: 20-DEC-12
SKANEATELES FALLS NY 13153 0020   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Q-PLUS T+ IPL LASER SYSTEM
QUANTA SYSTEM SPA                 510(k) NO: K123168(TRADITIONAL)
ATTN: MAURIZIO  BIANCHI           PHONE NO : 390 331376 797
VIA IV NOVEMBRE, 116              SE DECISION MADE: 20-DEC-12
SOLBIATE OLONA, VA    IT 21058    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: G.HLAMP
G.TEC MEDICAL ENGINEERING GMBH    510(k) NO: K123255(TRADITIONAL)
ATTN: CHRISTOPH  GUGER            PHONE NO : 437 251222 4012
SIERNINGSTRASSE 14                SE DECISION MADE: 20-DEC-12
SCHIEDLBERG    AU 4521            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
BAUSCH & LOMB, INC.               510(k) NO: K122575(TRADITIONAL)
ATTN: NANCY A FEHRMAN             PHONE NO : 585 338 5735   
1400 NORTH GOODMAN ST.            SE DECISION MADE: 20-DEC-12
ROCHESTER NY 14609 3547           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVA ONE BLOOD GLUCOSE MONITOR
NOVA BIOMEDICAL CORPORATION       510(k) NO: K122435(TRADITIONAL)
ATTN: PAUL W MACDONALD            PHONE NO : 781 894 0800   
200 Prospect St                   SE DECISION MADE: 20-DEC-12
WALTHAM MA 02454                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTERNAL FIXATOR SYSTEM
CHRISTOPHER D. ENDARA             510(k) NO: K122208(TRADITIONAL)
ATTN: CHRISTOPHER  ENDARA         PHONE NO : 305 491 9133   
11767 S. DIXIE HWY #313           SE DECISION MADE: 20-DEC-12
MIAMI FL 33156                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER
INTERSURGICAL, INC.               510(k) NO: K122075(TRADITIONAL)
ATTN: MICHAEL  ZALEEWSKI          PHONE NO : 315 451 2900   
417 ELECTRONICS PKWY.             SE DECISION MADE: 20-DEC-12
LIVERPOOL NY 13088                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE
3M COMPANY                        510(k) NO: K123085(TRADITIONAL)
ATTN: LISA  NELSON                PHONE NO : 651 733 2334   
2510 CONWAY AVENUE                SE DECISION MADE: 20-DEC-12
ST. PAUL MN 55144                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANESTHESIA CONDUCTION NEEDLES
SHANGHAI SA MEDICAL & PLASTIC INST510(k) NO: K120475(TRADITIONAL)
ATTN: MIKE  GU                    PHONE NO : 862 037 612981
7TH FL, JINGUI BUSINESS BLDG. NO. SE DECISION MADE: 21-DEC-12
BAIYUM DISTRICT, GUANGZHOU    CH 5510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AB COMMAND DUAL CHANNEL FITNESS BELT
LETO ENTERPRISES INCORPORATION    510(k) NO: K122414(SPECIAL)
ATTN: SABRINA  WEI                PHONE NO : 867 558 3089699
SUITE A-2706, ZHONGFANG JINGYUAN XSE DECISION MADE: 21-DEC-12
SHENZHEN    CH 518100             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
LIMACORPORATE S.P.A.              510(k) NO: K112898(TRADITIONAL)
ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220   
P.O. BOX 696                      SE DECISION MADE: 21-DEC-12
WINONA LAKE IN 46590 696          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: X-TRA BASE
VOCO GMBH                         510(k) NO: K123773(TRADITIONAL)
ATTN: T.  GERKENSMEIER            PHONE NO : 49 472171 9200
ANTON-FLETTNER-STRASSE 1-3        SE DECISION MADE: 21-DEC-12
CUXHAVEN    GM D-27472            510(k) STATEMENT

DEVICE: Z-LOOK3 EVO SLM
Z-SYSTEMS AG                      510(k) NO: K120793(TRADITIONAL)
ATTN: LINDA  SCHULZ               PHONE NO : 858 792 1235   
11234 EL CAMINO REAL STE: 200     SE DECISION MADE: 21-DEC-12
SAN DIEGO CA 92024                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABBOTT PLEX-ID FLU ASSAY
ABBOT LABORATORIES                510(k) NO: K121003(TRADITIONAL)
ATTN: DARREN  CLARKE              PHONE NO : 760 476 3224   
1300 EAST TOUHY AVENUE            SE DECISION MADE: 21-DEC-12
DES PLAINES IL 60018              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
ARROW INTERNATIONAL, INC.         510(k) NO: K122690(TRADITIONAL)
ATTN: PAUL  AMUDALA               PHONE NO : 610 378 0131   
2400 BERNVILLE RD.                SE DECISION MADE: 21-DEC-12
READING PA 19605                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPERT FLU
CEPHEID                           510(k) NO: K123191(TRADITIONAL)
ATTN: RUSSEL K ENNS               PHONE NO : 408 400 8230   
904 CARIBBEAN DRIVE               SE DECISION MADE: 21-DEC-12
SUNNYVALE CA 94089 1189           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
FAMIDOC TECHNOLOGY CO., LTD       510(k) NO: K113010(TRADITIONAL)
ATTN: CAO  LIANG                  PHONE NO : 867 552 7864342
East 2/F,Zhixiang Building,71 BLOCSE DECISION MADE: 21-DEC-12
SHENZHEN    CH 518101             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST
INSTITUT STRAUMANN AG             510(k) NO: K120822(TRADITIONAL)
ATTN: ANDREAS  PETERMANN          PHONE NO : 416 196 51482
PETER-MERIAN-WEG 12               SE DECISION MADE: 21-DEC-12
BASEL    SZ CH-4052               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERSARATE FLOW RATE CONTROLER
EMED TECHNOLOGIES CORPORATION     510(k) NO: K123729(TRADITIONAL)
ATTN: PETER  KOLLINGS             PHONE NO : 916 932 0071   
1264 Hawks Flight Ct Ste 200      SE DECISION MADE: 21-DEC-12
EL DORADO HILLS CA 95762          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: KYPHON EXPRESS II INFLATABLE BONE TAMPS
MEDTRONIC                         510(k) NO: K123771(SPECIAL)
ATTN: HETAL  JAWAHAR THAKKER      PHONE NO : 408 548 6500   
1221 CROSSMAN AVE.                SE DECISION MADE: 21-DEC-12
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F
VENOUS HEALTH SYSTEMS, INC.       510(k) NO: K122609(TRADITIONAL)
ATTN: RICH  LAGUNA                PHONE NO : 650 646 3327   
3270 Alpine Rd                    SE DECISION MADE: 21-DEC-12
Portola Valley CA 94028           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA TOTAL FOOT SYSTEMS
INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K123000(TRADITIONAL)
ATTN: STEPHEN H BEIER             PHONE NO : 609 936 5436   
311 ENTERPRISE DR.                SE DECISION MADE: 21-DEC-12
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645
INVIVO CORPORATION                510(k) NO: K122897(TRADITIONAL)
ATTN: LANCE  AULABAUGH            PHONE NO : 352 336 0010   
3545 SW 47TH AVE                  SE DECISION MADE: 21-DEC-12
GAINESVILLE FL 32608              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLOOKO LOGBOOK CHARTS
GLOOKO, INC.                      510(k) NO: K122142(TRADITIONAL)
ATTN: SHILPA  MYDUR               PHONE NO : 650 521 0175   
170A UNIVERSITY AVENUE            SE DECISION MADE: 21-DEC-12
PALO ALTO CA 94301                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
GEMORE TECHNOLOGY CO., LTD.       510(k) NO: K122944(SPECIAL)
ATTN: BODEN  S.P. LAI             PHONE NO : 88 62 88091799
11 FL, NO. 29-5, SEC. 2 CHUNG CHENSE DECISION MADE: 21-DEC-12
TAN SHUI, TAIPEI HSIEN    TW 251  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTURION VISION SYSTEM
ALCON LABORATORIES, INC.          510(k) NO: K121555(TRADITIONAL)
ATTN: CHARLES  OGBONNA            PHONE NO : 949 753 6307   
15800 ALTON PARKWAY               SE DECISION MADE: 21-DEC-12
IRVINE CA 92623                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
SONOSCAPE COMPANY LIMITED         510(k) NO: K123616(SPECIAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 237-023                  SE DECISION MADE: 21-DEC-12
SHANGHAI    CH 237-023            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K122961(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE.             SE DECISION MADE: 21-DEC-12
SUITE F GAITHERSBURG MD 20877     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON
ARTHREX, INC.                     510(k) NO: K123341(TRADITIONAL)
ATTN: CHRISTINA  FLORES           PHONE NO : 239 643 5553   
1370 Creekside Blvd               SE DECISION MADE: 21-DEC-12
Naples FL 34108                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MR4500 WHEELCHAIR
WARDRAY PREMISE LTD               510(k) NO: K120391(TRADITIONAL)
ATTN: JAMES  WASON PH.D.          PHONE NO : 603 672 4678   
7 VILLAGE WOODS DR                SE DECISION MADE: 21-DEC-12
AMHERST NH 03031                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREXION 3D
THE YOSHIDA DENTAL MFG. CO., LTD. 510(k) NO: K120948(TRADITIONAL)
ATTN: HIDENORI  WATANABE          PHONE NO : 813 363 12165
1-3-6 KOTOBASHI, SUMIDA-KU        SE DECISION MADE: 21-DEC-12
TOKYO    JA 130-8516              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
NXSTAGE MEDICAL, INC.             510(k) NO: K113023(TRADITIONAL)
ATTN: MARY LOU  STROUMBOS         PHONE NO : 978 687 4872   
439 SOUTH UNION ST., 5TH FLOOR    SE DECISION MADE: 21-DEC-12
LAWRENCE MA 01843                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CERAMIN BRACKETS Z
TOMY, INC.                        510(k) NO: K123092(TRADITIONAL)
ATTN: CAROLYN  PRIMUS             PHONE NO : 941 753 9737   
7046 OWL'S NEST TERRACE           SE DECISION MADE: 21-DEC-12
BRADENTON FL 34203                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAMILTON-C3
HAMILTON MEDICAL AG               510(k) NO: K123637(SPECIAL)
ATTN: RALPH  AGUILA               PHONE NO : 419 166 06845
VIA CRUSCH 8                      SE DECISION MADE: 21-DEC-12
BONADUZ, GRISONS    SZ 7402       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
SURGICAL SPECIALTIES CORP. DBA ANG510(k) NO: K123836(SPECIAL)
ATTN: KIRSTEN  STOWELL            PHONE NO : 610 404 3367   
100 DENNIS DR.                    SE DECISION MADE: 21-DEC-12
Reading PA 19606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KOGENT BIPOLAR FORCEPS
KATALYST SURGICAL, LLC            510(k) NO: K123172(TRADITIONAL)
ATTN: MONA  DEAN                  PHONE NO : 636 536 5950   
754 Goddard ave                   SE DECISION MADE: 21-DEC-12
Chesterfield MO 63005             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DETACHATIP III
CONMED CORPORATION                510(k) NO: K123260(TRADITIONAL)
ATTN: LISA  ANDERSON              PHONE NO : 315 624 3217   
525 FRENCH RD.                    SE DECISION MADE: 21-DEC-12
UTICA NY 13502                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-CUBE 7
ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K123611(TRADITIONAL)
ATTN: DONGHWAN  KIM               PHONE NO : 827 074 652068
1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 21-DEC-12
SEOUL    KS 152-848               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM
PHILIPS ULTRASOUND, INC.          510(k) NO: K123754(TRADITIONAL)
ATTN:                             PHONE NO : 
3000 MINUTEMAN RD.                SE DECISION MADE: 21-DEC-12
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: GEM-STIM COMBO STIMULATOR
GEMORE TECHNOLOGY CO., LTD.       510(k) NO: K122948(SPECIAL)
ATTN: BODEN  S.P. LAI             PHONE NO : 88 62 88091799
11 FL, NO. 29-5, SEC. 2 CHUNG CHENSE DECISION MADE: 21-DEC-12
TAN SHUI, TAIPEI HSIEN    TW 251  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
TIGER MEDICAL PRODUCTS LTD        510(k) NO: K122717(ABBREVIATED)
ATTN: DAVID  WANG                 PHONE NO : 86 21 63866300
1 HUAIHAI ZHONG ROAD LIU LIN TOWERSE DECISION MADE: 21-DEC-12
SHANGHAI    CH 200021             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE
VERN MEDICAL TECHNOLOGIES         510(k) NO: K122106(TRADITIONAL)
ATTN: SCOTT  WRIGHTSTONE          PHONE NO : 314 659 8500   
1908 INNERBELT BUSINESS CENTER DRISE DECISION MADE: 21-DEC-12
ST. LOUIS MO 63114                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PANTHER OIS/R & V MODEL VERSION 2.0
PROWESS, INC.                     510(k) NO: K122616(TRADITIONAL)
ATTN: RACHEL  SCARANO             PHONE NO : 925 356 0360   
1844 Clayton Road                 SE DECISION MADE: 21-DEC-12
Concord CA 94520                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSTEK WRIST BLOOD PRESSURE MONITOR
ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K123669(SPECIAL)
ATTN: LEO  WANG                   PHONE NO : 086 28 86083300
NO. 1 FANGHUA STREET HI-TECH DISTRSE DECISION MADE: 21-DEC-12
CHENGDU, SICHUAN    CH 610041     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K123017(SPECIAL)
ATTN: NANCY  CHU                  PHONE NO : 949 453 6435   
33 TECHNOLOGY DRIVE               SE DECISION MADE: 26-DEC-12
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUICK SAMPLER HOLDER
NIPRO MEDICAL CORPORATION         510(k) NO: K120490(TRADITIONAL)
ATTN: JESSICA  OSWALD             PHONE NO : 305 599 7174   
3150 N.W. 107TH AVE.              SE DECISION MADE: 27-DEC-12
MIAMI FL 33172                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)
SAPPHIRE MEDICAL GROUP, INC       510(k) NO: K121693(TRADITIONAL)
ATTN: ROBERT  POGGIE              PHONE NO : 973 738 6097   
815 IRIS LANE                     SE DECISION MADE: 27-DEC-12
VERO BEACH FL 32963               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVA SELECT DIGITAL DENTAL IMAGING SYSTEM
AFP IMAGING CORP.                 510(k) NO: K123419(SPECIAL)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234 1735   
8870 RAVELLO CT.                  SE DECISION MADE: 27-DEC-12
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
AEROCRINE AB                      510(k) NO: K123683(SPECIAL)
ATTN: KATHLEEN  RICKARD, MD       PHONE NO : 001 919 7496708
SUNDBYBERGSVAGEN 9                SE DECISION MADE: 27-DEC-12
SOLNA    SW 17173                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT
BIONESS, INC.                     510(k) NO: K122784(TRADITIONAL)
ATTN: KIM  TOMPKINS               PHONE NO : 661 362 5968   
25103 RYE CANYON LOOP             SE DECISION MADE: 27-DEC-12
VALENCIA CA 91355                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
BIO-RAD LABORATORIES              510(k) NO: K123663(TRADITIONAL)
ATTN: SUZANNE  PARSONS            PHONE NO : 949 598 1467   
9500 JERONIMO RD.                 SE DECISION MADE: 27-DEC-12
IRVINE CA 92618 2017              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)
MEDTRONIC CRYOCATH LP             510(k) NO: K123591(SPECIAL)
ATTN: VANESSA  WARE               PHONE NO : 763 526 2743   
8200 CORAL SEA STREET NE MS MVS46 SE DECISION MADE: 27-DEC-12
MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLEXLITE CAMERA
SPINE VIEW, INC.                  510(k) NO: K122134(TRADITIONAL)
ATTN: MBITHI  MUTHINI             PHONE NO : 510 743 5090   
48810 Kato Rd. Suite 100E         SE DECISION MADE: 27-DEC-12
Fremont CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPERT CT/NG
CEPHEID                           510(k) NO: K121710(TRADITIONAL)
ATTN: RUSSEL K ENNS               PHONE NO : 408 400 8230   
904 CARIBBEAN DRIVE               SE DECISION MADE: 27-DEC-12
Sunnyvale CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
IMRIS, INC.                       510(k) NO: K123091(TRADITIONAL)
ATTN: SANJAY  SHAH                PHONE NO : 204 480707 0
100-1370 SONY PLACE               SE DECISION MADE: 27-DEC-12
WINNIPEG, MB    CA R3T 1N5        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS
CARL ZEISS MEDITEC, INC.          510(k) NO: K121653(TRADITIONAL)
ATTN: SARAH  HARRINGTON           PHONE NO : 925 560 5134   
5160 HACIENDA DRIVE               SE DECISION MADE: 27-DEC-12
DUBLIN CA 95030                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EZ-ASSIST-FILL
ASSIST FILL, LLC                  510(k) NO: K121661(TRADITIONAL)
ATTN: GRIFFIN                     PHONE NO : 704 843 1675   
55 NORTHERN BLVD STE 200          SE DECISION MADE: 27-DEC-12
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRESTIGE-MOBIE
PRESTIGE SPORTING GOODS CO. LTD.  510(k) NO: K122749(TRADITIONAL)
ATTN: JUNNATA  CHANG              PHONE NO : 886 4 22465396
16F-2(16A), NO. 462, SEC. 2 CHONGDSE DECISION MADE: 27-DEC-12
TAICHUNG    TW 406                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARREAD +CONFIRM
RIVERAIN TECHNOLOGIES             510(k) NO: K123526(TRADITIONAL)
ATTN: JENNIFER  BUTSCH            PHONE NO : 937 425 6811   
3020 SOUTH TECH BLVD.             SE DECISION MADE: 27-DEC-12
MIAMISBURG OH 45324               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
KETTENBACH GMBH & CO KG           510(k) NO: K122039(TRADITIONAL)
ATTN: JUERGEN  BERGER             PHONE NO : 49 277 47050
IM HEERFELD 7                     SE DECISION MADE: 27-DEC-12
ESCHENBURG    GM 35713            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
SIAM SEMPERMED CORP. LTD.         510(k) NO: K121549(ABBREVIATED)
ATTN: WILLIAM E HARRIS            PHONE NO : 727 787 7250   
13900 49TH STREET NORTH           SE DECISION MADE: 27-DEC-12
CLEARWATER FL 33762               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO SINGLE SOURCE DUAL ENGERY
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K122909(TRADITIONAL)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 448 4912   
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 27-DEC-12
MALVERN PA 19355 1406             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPID STRAND RX
MEDI-PHYSICS, INC.                510(k) NO: K122764(TRADITIONAL)
ATTN: DAVID  RISLEY               PHONE NO : 609 514 6489   
3350 NORTH RIDGE AVE.             SE DECISION MADE: 28-DEC-12
ARLINGTON HEIGHTS IL 60004        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1
DELTA MED SRL                     510(k) NO: K121007(TRADITIONAL)
ATTN: HARRY  BONTRAGER            PHONE NO : 630 654 4243   
721 KRISTIN COURT                 SE DECISION MADE: 28-DEC-12
WESTMONT IL 60559                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
SEKISUI DIAGNOSTICS, LLC          510(k) NO: K121397(TRADITIONAL)
ATTN: MARK  STAVRO                PHONE NO : 858 777 2633   
6659 Top Gun St                   SE DECISION MADE: 28-DEC-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LANSINOH POWERED ELECTRIC BREAST PUMP
LANSINOH LABORATORIES SAGLIK GEREC510(k) NO: K122474(SPECIAL)
ATTN: CALLEY  HERZOG              PHONE NO : 720 883 3633   
13417 QUIVAS ST                   SE DECISION MADE: 28-DEC-12
WESTMINSTER CO 80234              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONQ RTS
ONCOLOGY SYSTEMS, INC.            510(k) NO: K123357(TRADITIONAL)
ATTN: LU ANNE  JOHNSON            PHONE NO : 715 403 5321   
1917 29 3/4 AVE.                  SE DECISION MADE: 28-DEC-12
RICE LAKE WI 54868                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
SIGNATURE ORTHOPAEDICS, PTY, LTD  510(k) NO: K121297(TRADITIONAL)
ATTN: DECLAN  BRAZIL              PHONE NO : 011 612 94115514
125 GREVILLE ST                   SE DECISION MADE: 28-DEC-12
CHATSWOOD    AU 2067              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM
MEDOS INTERNATIONAL SARL          510(k) NO: K123167(TRADITIONAL)
ATTN: EUGENE  BANG                PHONE NO : 508 977 3966   
325 PARAMOUNT DRIVE               SE DECISION MADE: 28-DEC-12
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIPIVIEW OCULAR SURFACE INTERFEROMETER
TEARSCIENCE, INC.                 510(k) NO: K122481(TRADITIONAL)
ATTN: CHRISTY  STEVENS            PHONE NO : 919 459 4815   
5151 McCrimmon Parkway Suite 250  SE DECISION MADE: 31-DEC-12
Morrisville NC 27560              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESPIRONICS SIMPLYCLEAR DEVICE
RESPIRONICS, INC.                 510(k) NO: K122111(ABBREVIATED)
ATTN: COLLEEN  WITT               PHONE NO : 724 387 4870   
1740 GOLDEN MILE HIGHWAY          SE DECISION MADE: 31-DEC-12
MONROEVILLE PA 15146              510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   279                                     
                                                 TOTAL WITH SUMMARIES        261                                     
                                                 TOTAL WITH STATEMENTS        18